CN103691061A - 用于对心搏进行准确分类的方法和设备 - Google Patents
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Abstract
用于植入的心脏监控和治疗设备(诸如可植入式心脏复律除颤器)中的信号分析的方法、系统和设备。在一些示例中,包括所检测事件的捕获数据被分析以识别心脏事件的可能过检测。在一些说明性示例中,当识别出过检测时,数据可以被修改以校正过检测,从而降低过检测的影响,或者忽略过检测数据。若干示例强调将相关性用于静态模板和/或事件间相关性分析的形态分析的使用。
Description
相关申请
本申请为分案申请,其母案的发明名称为“用于对心搏进行准确分类的方法和设备”,申请日为2009年5月7日,申请号为200980125869.6。
本申请要求保护2008年5月7日提交的名称为METHODS AND DEVICES FOR IDENTIFYING AND CORRECTING OVERDETECTION OF CARDIAC EVENTS美国临时专利申请号为61/051,332的权益和优先权,并且是2009年3月6日提交的名称为METHODS AND DEVICES FOR ACCURATELY CLASSIFYING CARDIAC ACTIVITY的美国专利申请序列号为12/399,914的部分连续案,通过参考将其引用于此。
本申请与2009年3月6日提交的名称为ACCURATE CARDIAC EVENT DETECTION IN AN IMPLANTABLE CARDIAC STIMULUS DEVICE的美国专利申请序列号12/399,901有关,其要求保护2008年3月7日提交的美国临时专利申请号61/034,938的权益和优先权,通过参考将其引用于此。
技术领域
本发明总体上涉及感测和分析心脏信号的可植入式医疗设备系统。更特别地,本发明涉及在被植入者(implantee)身体内捕获心脏信号以便有将心搏分类为可能良性或恶性的可植入式医疗设备。
背景技术
可植入式心脏设备典型地感测被植入者内的心脏电信号并且将被植入者的心律分类为正常/良性或恶性。所说明的恶性心律可以包括室颤和/或室速。可植入式医疗设备分析所捕获的信号的准确度确定其进行治疗和其他决策得有多好。
期望用于心脏信号分析的新的和/或可替换的方法和设备。
发明内容
一些说明性实施例涉及使用相关性(correlation)分析来识别心脏事件的过检测(overdetection)。在一个示例中,寻找与模板有关的相关性的高-低-高模式。该模板可以是静态模板,它可以是最近所捕获的事件的表示,或者它可以是若干最近所捕获的事件的平均。在另一示例中,定义针对高相关性的多个边界,其中第一较高边界(需要更多相关性)允许基于比第二较低边界更小的所检测事件的集合来识别过检测。在一个实施例中,在第一边界的情况下,高-低-高的较短序列足够,而对于第二边界,需要五个或更多(例如八个)交替事件的较长序列。在另一实施例中,通过使用针对所检测事件相关性的子集的平均值来建立边界,高和低相关性的定义适应于特定信号。
在另一实施例中,通过移位模板和所检测事件的对准(alignment)来针对给定模板和所检测事件多次执行相关性分析以最大化分析的相关性得分。这样的移位可以将所述对准调整远离所识别的基准点一个或多个采样以用于分析。在另一实施例中,所存储的模板被修改以便适应所选的信号部分的形态(morphology)的变化。在又一实施例中,模板和/或信号的多个特征被识别,并且使用若干不同特征作为对准点来计算多个相关性得分。
当被识别时,可以通过修改所存储的数据来校正过检测以便影响速率分析。在一个这样的实施例中,如果可能的过检测周围的间隔不比预定阈值长,则禁止数据校正。在一些实施例中,如果与可能的过检测有关的间隔分析指示它不可能成为特定类型的过检测,则禁止过检测校正。在一个这样的实施例中,分析可能的过检测周围的间隔以确定所接受的用于估计期望QT间隔的公式是否被满足,并且如果没有满足,则该方法确定可能的过检测不是T波(T-wave),并且所以不发生数据校正。
附图说明
图1是识别过检测和采取校正动作的说明性方法的框图。
图2示出说明性可植入式心脏刺激系统。
图3A示出使用相关性分析来识别过检测的示例。
图3B说明包括速率校正的说明性示例的方法步骤。
图4示出事件间相关性比较的示例。
图5示出事件间相关性比较的另一示例。
图6示出短系列和长系列相关性分析的分析方法。
图7A-7B说明将图6的分析方法应用于一系列相关性分析的示例。
图8A-8B说明使相关性分析适合于所观察到的与模板的相关性的等级的示例。
图9说明将所捕获的信号对准到相关性分析模板的另一方法。
图10示出存储并应用用于相关性分析的模板的另一方法。
图11-12说明禁止过检测的相关性分析识别的方法。
图13说明用于禁止过检测的相关性分类识别的多个方法。
图14A-14B示出在图13中说明的方法的应用。
图15示出用于识别可电击(shockable)所检测事件和可治疗心律的电击分析方法;以及。
图16说明计算所捕获信号和模板之间的相关性的方法。
具体实施方式
应该结合附图来阅读下面的详细描述。不一定按缩放比例绘制的图描绘说明性实施例并且不意图限制本发明的范围。下面的一些示例和解释包括对所授权的专利和待决专利申请的参考。这些参考用于说明性目的并且不意图将本发明限制成来自这些所参考的专利和专利申请的特定方法或结构。
除非含蓄地需求或明确地阐述,下面的方法不需要步骤的任何特定次序。应该理解,当下面的示例指的是“当前事件”时,在一些实施例中,这意味着大多数最近检测的心脏事件被分析。然而,不一定是这种情况,并且一些实施例执行延迟一个或多个检测和或固定时间段的分析。所示出的关于整流的/未整流的信号的使用的选择仅是说明性的并且可以根据期望而改变。
在此处所使用的术语指示由可植入式心脏设备系统来感测信号,在所感测的信号中检测事件,以及通过使用所检测事件(检测)来对心搏进行分类。心律分类包括恶性心律(例如室颤或室速)的识别。可植入式治疗系统根据心律的分类而进行治疗/刺激决策。
在所说明的示例中,通过比较所接收的信号和检测阈值来检测所检测事件,所述检测阈值由检测图形(profile)来定义。可以使用任何适当的检测图形。所检测事件可以由间隔分开。若干间隔可以被用来生成所选数目的间隔的平均间隔,根据其可以计算心率。例如,四个、八个或十六个间隔可以被用来根据平均间隔估计心脏事件速率。
根据公知的传统,心脏电描记图包括若干部分(通常被称为“波”),其被包括P、Q、R、S和T的字母标记,它们中的每一个都对应于特定的生理事件。典型地是设计检测算法来感测R波,不过可以是心动周期的任何部分,如果被重复检测,则它可以被用来生成心跳速率。如果除了心跳速率之外还使用了形态(形状)分析,则该系统可以捕获和/或分析包括Q、R和S波(其被称为QRS复合波)的周期的部分。病人心动周期的其他部分(例如P波和T波)通常被当作伪影(artifact)(其中所述伪影不为了估计心跳速率的目的来寻找的),不过情况无需是这样。
典型地,为了查明速率,每个心动周期仅被计数一次。如果设备在单个心动周期内声明多于一个所检测事件,则可能发生过检测(例如双或三检测)。如果检测到单个心动周期的多于一个部分,或者如果没有发生例如因外部治疗或噪声、心脏起搏(pacing)伪影、骨骼肌噪声、电疗法等等而引起的心脏事件时噪声造成事件被声明,则可能发生过检测。
如果发生一个心动周期并且检测算法声明多个所检测事件,则发生了过检测。如果然后通过计数这些检测中的每一个来计算心跳速率,则发生过计数。所计算的心跳速率可以被单独使用或者结合其他因素使用以便将心律分类为恶性的或良性的。依赖于过检测事件的过计数可以产生有错误的高速率计算。心跳速率的错算可以导致不正确的心律分类和治疗决策。在名称为METHODS AND DEVICES FOR ACCURATELY CLASSIFYING CARDIAC ACTIVITY并且序列号为12/399,914的美国专利申请,以及名称为ACCURATE CARDIAC EVENT DETECTION IN AN IMPLANTABLE CARDIAC STIMULUS DEVICE并且序列号为12/399,901的美国专利申请中进一步讨论并研究了这些概念中的一些概念。
图1是识别过检测并且采取校正动作的说明性方法的过程流程图。说明性方法以事件检测10开始,其中捕获所接收的心脏信号,并且将该心脏信号与检测阈值相比较直到所接收的信号跨过检测阈值为止,从而导致所检测事件的声明。
接着,该方法执行过检测识别步骤12。这可以包括若干分析方法中的一个或多个,如说明性示出的那样,所述分析方法包括形态分析14、间隔分析16和宽QRS分析18。在过检测识别12之后,如果识别出一个或多个过检测,则该方法校正数据,例如在20处示出的那样。如果在步骤20处不需要数据校正,所以该步骤可以被绕过。
最后,该方法包括治疗决策,如在22处示出的那样。治疗决策22可以将被植入者的心律分类,并且确定是否治疗被递送/何时递送该治疗。然后,该方法重复到事件检测10。
治疗决策22可以包括若干分析形式中的一个或多个。在一个说明性示例中,单独所检测事件可以被标记为可电击的或非可电击的,并且X/Y(X-out-of-Y)计数器被保持以确定整体心律是否应得治疗。将单独事件标记为可电击的或非可电击的可以采用若干形式,包括基于速率的和/或基于形态的确定,或者其结合。下面的图15提供了说明性示例。还在名称为APPARATUS AND METHOD OF ARRHYTHMIA DETECTION IN A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR专利号为6,754,528的美国专利和名称为METHOD FOR DISCRIMINATING BETWEEN VENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS专利号为7,330,757的美国专利中公开了其他示例,通过参考将其公开引用于此。
治疗决策22还可以考虑恶性状况的持续性。在名称为METHOD FOR ADAPTING CHARGE INITIATION FOR AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR公布号为2006/0167503的美国专利申请中示出一些说明性示例,通过参考将其公开引用于此。其他方法还可以被用作治疗决策22的一部分。
图2示出说明性可植入式医疗设备和植入位置。更特别地,在图2中示出了说明性仅皮下用系统。关于心脏40示出了该皮下系统,并且该皮下系统包括耦合到引线(lead)46的罐(canister)42。该罐42优选地容纳用于执行心搏分析并且用于提供治疗输出的操作电路。该操作电路可以包括本领域已知的电池、输入/输出电路、电力电容器、高压充电模块、控制器、存储器、遥感部件等等。
布置在遍及系统的位置处的电极包括例如罐42上的电极44以及引线46上的电极48、50、52。电极44、48、50、52可以采用任何适当的形式,并且可以由任何适当的材料制成。例如,罐电极44可以是隔离的按钮电极或者它可以是罐42的区域或表面,并且引线46上的电极48、50、52可以是线圈电极、环形电极或本领域中已知的其他结构。
电极44、48、50、52定义多个感测矢量,例如V1、V2、V3和V4。如果需要,一个或多个矢量V1、V2、V3和V4可以被选为缺省感测矢量,例如,如在名称为SYSTEMS AND METHODS FOR SENSING VECTOR SELECTION IN AN IMPLANTABLE MEDICAL DEVICE公布号为2007-0276445的美国专利申请中所讨论的那样。例如,在名称为MULTIPLE ELECTRODE VECTORS FOR IMPLANTABLE CARDIAC TREATMENT DEVICES专利号为7,392,085的美国专利中示出了多个矢量的其他使用。另一实施例考虑了矢量分析中的姿势,例如,如在名称为SENSING VECTOR SELECTION IN A CARDIAC STIMULUS DEVICE WITH POSTURAL ASSESSMENT公布号为2008-0188901的美国专利申请中所讨论的那样。根据需要,可以顺序或组合地分析多个感测矢量。
可以使用任何选择的电极对来应用治疗。说明性示例使用罐电极44和线圈电极52来应用治疗。可以使用其他电极组合。治疗可以包括单相或多相去颤、心脏复律(cardioversion)和/或心脏起搏。
本发明不限于任何特定硬件、植入位置或配置。作为代替,它意图作为对任何可植入式心脏治疗系统的改进。一些实施例还可以被用于监控系统中,以控制监控功能(包括通告和/或数据记录)和/或测试对特定配置、状况或病人的数据分析的适用性。
一些说明性示例可以与被配置成与用于各种用途的可植入式设备通信的外部编程器54相关联,其包括例如但不限于下述各项中的一个或多个:设备测试、上载新/修订的软件;修改可编程参数(例如检测或治疗设置);确定设备操作的状态、电池寿命或引线牢固性;启用或禁用功能;和/或在数据捕获或治疗之前下载与被植入者的状况有关的数据。可以使用任何适当的通信方法,例如本领域中广泛已知的各种协议和硬件。
图2省略了一些解剖标志。所示出的说明性系统可以被植入到被植入者的皮肤下面、胸腔之外。说明性示出的位置将罐42放在被植入者左腋窝附近、与心尖齐平,其中引线46从中间朝向剑突(xiphoid)延伸并且然后沿着胸骨的左侧朝向被植入者的头部。一个说明性示例使用在共同转让的名称为APPARATUS AND METHOD FOR SUBCUTANEOUS ELECTRODE INSERTION、公布号为2006-0122676的美国专利申请中示出的方法/系统。在共同转让的专利号为6,647,292、6,721,597和7,149,575的美国专利中示出其他说明性皮下系统和位置。
本发明还可以被嵌入在具有各种植入式配置的系统中,其包括例如其他仅皮下的、仅脉管的和/或经静脉的植入配置/位置。罐42可以被放在前部的、侧部的和/或后部的位置,其包括但不限于腋窝、胸部和胸部下面的位置,以及被植入者躯干的左侧或右侧和/或腹部中的位置。已提出了系统的整体血管内植入。罐42和引线46可以被放在任何多个适当的配置中,其包括前部-后部结合、仅前部结合、经静脉的放置或其他脉管放置。单一系统可以省略引线46并且作为代替包括罐42上的所有电极。
图3A示出使用相关性分析来识别过检测的示例。此处所使用的“相关性分析”可以采取若干形式。在图16中示出了一个说明性示例。参考图16,所捕获的信号500经过模拟到数字转换502,以产生采样的时序系列{S1…S9},其形成信号的采样(并且通常是数字)表示,如在504处所指示的那样。为了说明,图16中的示例被简化,针对给定信号,采样数目可以大于9。例如,在一个说明性实施例中,所捕获的信号500大于为160毫秒长,以256Hz覆盖所捕获的41个采样。可以选择其他持续时间和/或采样频率。信号可以被窗口化成大约QRS宽度,不过这不是必需的。
使用相关性分析506将信号表示和模板相比较。该模板被示出为包括一系列采样值{T1…T9}。在比较之前,或者作为比较的一部分,信号表示或模板被缩放(scale)以使得两个数据集合的最大峰值在幅度上相等。相关性分析的一个示例是相关性波形分析。本领域广泛地已知其他示例。
在图16中用图表示出相关性分析的单个版本:信号表示的最大采样或峰值与模板的峰值对准,并且将周围的采样彼此比较,如在508处示出的那样。因为峰值已被缩放为相等,所以在峰值处不存在差,但是周围的采样可能不同。信号表示和模板之间的差以交叉阴影线示出。
接着,可以如在510处示出的那样计算相关性得分。信号表示的(缩放的)采样和模板的采样之间的差的绝对值的和被计算并且除以模板下的总面积。从1减去商,从而产生相关性得分512。如果相关性得分接近1,则相对于模板下的面积,差的面积很小,这指示高相关性。现有技术中已知用于计算相关性的其他方法并且其可以被代替;在图16中示出的仅仅是示例。例如,加权的CWA可以以在共同转让的待决美国专利申请公布号2008-0077030中示出的方式将加权因子应用于单独采样差。
返回到图3A,通过将检测图形70应用于信号72来检测单独事件。检测图形70包括不反应(refractory)时段74,之后是恒定阈值时段76和衰变时段78。可以针对检测图形70使用其他形状。
信号72具有被突出的T波和R波。在所示的示例中,相对于R波,T波是大的。在R波和T波这二者上以交叉阴影线示出的不反应时段指示每个R波和每个T波被当作为所检测事件。结果,对于每个心动周期,检测图形70检测两个事件。这是过检测的一个示例。
在所说明的示例中,单独检测中的每一个还被当作相对于基于R波的模板的相关性分析。在80处绘制相关性分析的结果。绘图80包括针对“高”和“低”相关性的边界。在该示例中,每个“X”指示每个所检测事件的相关性得分。相关性得分的高-低-高模式如在82处示出的那样发生。在该示例中,每个高-低-高序列产生一个结论:得分为“低”的所检测事件被过检测。结果,如所示出的那样,当发现高-低-高模式时将会丢弃得分为“低”的所检测事件。在数值示例中,当使用图16中在510处示出的形式进行计算时,大于52%的相关性被定义为“高”,而小于25%的相关性被定义为“低”。可以使用其他值和分析方法。
图3B说明针对包括速率校正的说明性示例的方法步骤。一旦发现形态过检测模式,如在90处指示的那样,就如在92处示出的那样识别一个或多个过检测。接着,如在94处示出的那样,重新计算事件间隔和/或速率。
例如,如在96处示出的那样,一系列R波和T波的检测可以导致225ms(R到T)和300ms(T到R)的间隔计算集合,这产生263ms的平均间隔。263毫秒的平均间隔产生每分钟大约229跳的速率,这将是在许多病人中可治疗的快速性心律失常(tachy-arrhythmia)。然而,当T波被识别为过检测并且T波任一侧上的间隔被组合时(如在98处示出的那样),间隔平均为525毫秒。该速率可以被重新计算为每分钟大约114跳,从而避免在没有数据校正的情况下将产生的可能的去颤、心脏复律或心脏起搏。
图4示出了事件间相关性比较的示例。事件间比较是其中将两个单独的所检测事件彼此比较的一种比较。该比较可以采用相关性分析的形式,或者它可以使用一些其他类型的分析,例如小波变换、主成分分析(PCA)等等来考虑两个所检测事件之间的相似性。在小波变换或PCA比较中,可以比较压缩成小波或PCA输出的数据结果的相似性。例如,可以以定性或定量地方式比较PCA的本征值输出的相似性和/或次序,或者从小波变换产生的小波系数的相似性。
在如图4所示的示例中,执行相关性分析。在该示例中,如在108处示出的那样,相关性得分被表征为低、中或高。“高”得分区指示所比较的信号是相同符号的强可信度(例如,如果一个是R波,则另一个也是R波),而“低”得分指示所比较的信号彼此非常不同。“中”区旨在捕获那些相似但是没有产生两个信号是相同符号的强可信度的信号。例如,在经受与速率有关的形态变化(例如速率感应的束阻滞(bundle block))的病人中,所捕获的R波可能不与所存储的静态模板高度相关,但有可能落入与模板有关的中范围内。在另一示例中,单形态VT有可能具有R波之间的高或中事件间相关性,以及T波之间的中相关性,而多形态VT将示出R波之间的中或低相关性。
如果需要,可以应用模糊逻辑。“中区”的使用表明这一点。例如,可以提供附加的种类,而不是简单的“高”和“低”特征。此外,可以使用先前的测量来通知在边界上相似或不相似的信号的后续表征。
如在100处示出的那样,一系列事件N,N-1,N-2和N-3被视为一个组群,其中经由相关性分析将第N个检测与N-1,N-2和N-3中的每一个相比较。在102处,在表格中示出事件间比较和与静态模板的比较的结果。在104处示出事件间比较结果,并且其包括给定事件和三个在先事件的比较的有序结果。表格102示出事件N,N-1,N-2和N-3的结果。事件间比较的结果示出,对于任何给定的事件X,与X-2的相关性高于与X-1或X-3的相关性。这可以指示基于交替事件之间增加的相关性的双检测模式。
在说明性示例中,还可以执行与静态正常窦性心律(sinus rhythm)模板的比较。在106处示出了说明性结果。交替静态模板结果,低-中-低-中暗示可能的过检测,但是因为可能的R波不是高度相关,所以不会单独基于静态模板来产生强可信度。然而,当组合事件间比较信息时,存在一些事件是过检测的显著可信度。可应用的规则集可以如下:
1)当与N-1,N-2和N-3相比较时针对N的交替低-高-低;以及
2)当与N-3,N-4和N-5相比较时针对N-2的交替低-高-低
结论:将N-1和N-3当作T波
更进一步的确认规则可以是:
3)针对N和N-2与静态模板的至少“中”相关性
另一方法是仅应用规则1)和3),且同时响应于满足该规则集,仅将N-1标记为过检测。一旦一个或多个事件被标记为过检测,就以上面在图3B中示出的方式来对待它们。
图5示出事件间相关性比较的另一示例,在此处所捕获的信号被三检测,如在120处所示出的那样。在该实例中,将第N次检测与N-1、N-2、N-3和N-4中的每一个相比较。四个单独比较的结论可以进一步帮助区分三检测和双检测,不过一些实施例止于三个比较。
在124处的表格中示出了结果。对于每个比较集合,存在三个低相关性、以及一个中或一个高相关性。有可能利用三检测,一些检测将在每个比较中具有低相关性。说明性的规则集如下:
1.第N个事件具有与第N-3个事件的高相关性;
2.第N-1和N-2个事件具有与第N个事件的低相关性;以及
3.第N-1和N-2个事件具有与静态模板的低相关性。
如果这三个条件都满足,则可以丢弃N-1和N-2。可以添加其他条件。例如,还可以考虑N和/或N-3的静态模板特性,例如:
4.第N和N-3个事件具有与静态模板的中或高相关性
于是,如果1-4所有都满足,则可以丢弃N-1和N-2并且计算从N到N-3的间隔并且在速率分析中使用该间隔。
在另一示例中,还可以考虑每个事件的宽度,例如使用该第四条件:
5.第N-1和N-2事件比宽度阈值要宽
可以根据需要来设置宽度阈值;在一个示例中,宽度阈值在100-140ms的范围中。该宽度阈值规则可以被应用为对关于事件可以被作为过检测而丢弃的任何确定的附加层。在另一示例中,可以考虑极性(polarity):
6.N-1和N-2每一个都共享相同极性。
例如通过参考针对一个事件的大多数信号采样将极性定义为具有事件中的最大幅度的采样的极性,或者通过确定在事件中首先发生哪个极端(最肯定(most positive)或最不肯定(least positive))来定义极性。
如果需要,可以将间隔耦合添加为另一条件:
7.N到N-3的组合间隔小于持续时间
其中“持续时间”在800ms到1200ms的范围内。还结合下面的图11-13和14A-B来解释这种条件和其变型。
图6示出短系列和长系列相关性分析的分析方法。图6示出用于绘制一系列所检测事件的相关性得分的绘图140。对照定义宽带148的线144和146,以及定义窄带154的线150、152绘制被示出为X的相关性得分。
例如如图7A所示出的那样,当存在被得分低于线146的单个所检测事件分开的两个得分高于线144的所检测事件时,应用宽带148来识别过检测。例如如图7B所示出的那样,当一系列连续检测交替高于线150并低于线152时,应用窄带来识别(一个或多个)过检测。为了说明目的,示出针对每个阈值的数字;这些数字可以将相关性用作百分比。
关于相关性得分,较窄带154应用没有较宽带152那么严格的标准,并且因此在做出丢弃低得分事件的判定之前分析更多事件。在一个所说明的示例中,不使用窄带154来丢弃事件,直到满足在图7B中示出的8事件模式为止,在该点处丢弃低得分事件中的一个到四个事件,其中每个所丢弃的事件周围的间隔被校正。在满足初始步骤中的模式之后,将丢弃仅最新的低得分事件。为了分析目的,先前丢弃的事件将被用来确定是否满足8连续之外(8-consecutive-outside)规则,即使这些事件被排除在速率计算之外。另一实施例使用仅五个事件,使用较窄带154寻找高-低-高-低-高序列,并且如果发现这样的序列,则丢弃低得分事件的一个或二者。
在图6和图7A-7B中的示例指示数字,其中50%和20%相关性界定(border)宽带148,并且40%和25%界定窄带154。这些数字仅仅是说明性的。在一个示例中,通过将在图16的510处示出的公式定标为百分比基础来应用这些数字。
图8A-8B说明使相关性分析适合于所观察到的与模板的相关性的等级的示例。参考图8A,在158处示出了将模板和一系列事件比较的相关性得分的绘图。为了识别双检测,计算以奇数编号的事件的平均相关性得分。然后,通过例如使用集合的标准偏差或使用固定距离确定所有以奇数编号的事件是否都落入离平均值预定义的距离内来分析以奇数编号的事件的聚集。如果所有以奇数编号的事件都落入离平均值预定义的距离内,则计算平均值离低边界的间距(separation)。如果该间距大于预定阈值,则确定以奇数编号的事件表明单调性(monotonicity),该单调性支持以奇数编号的事件是QRS复合检测的假设。如果识别以奇数编号的事件的单调性,则落到低阈值之下的一个或多个以偶数编号的事件被标记为过检测。
在另一实施例中,在以偶数编号的事件中的任一个被标记为过检测之前,再次使用这些事件的平均值来分析它们全部以确定是否已发生以偶数编号的事件的聚集。计算偶数事件和奇数事件的平均值之间的间距而不是以奇数编号的事件平均值离低边界的间隔以建立事件的组群。在该实施例中,仅在发生以偶数编号的事件的足够聚集时才应用过检测标记。
图8B示出其中过检测的标记适合于与静态模板的相关性得分的另一示例。在此处,计算对于10个事件集合的平均相关性得分。然后在平均相关性得分周围建立“空白”带。例如,空白带可以被定义为+/-15%。可以使用其他“空白带”大小。
在图8B的示例中,高得分被定义为落到空白带之上的那些得分,并且低得分是落到空白带之下的那些得分。如果高-低-高的模式发生在空白带周围,则过检测可以被识别并且低得分事件的一个或多个被标记为过检测。
作为静态模板的代替,也可以将最近所检测的事件用作比较的模板来应用图8A-8B所示出的分析。针对图8A-8B指出的分析可以使用平均值/平均的计算,或者它可以使用针对包括模式、中值或其他数学运算的信号的中心点的某种其他预测器。
可以在确定是否发生可电击心律的确定中进一步使用此处示出的事件间比较。通常使用刺激递送来解决多形态状况,例如多形态室速和室颤。可以治疗诸如单形态室速(MVT)之类的单形态状况,但是MVT不总需要能量最大的(most energetic)治疗。例如,可以代替去颤或心脏复律而使用抗心动过速起搏(ATP)来治疗MVT。因为TAP使用较少的能量并且对病人产生的创伤较小。相关性的模式可以被用来区别单形态心律不齐和多形态心律不齐。例如,如果需要,可以使用在图7A或7B、或者甚至图6中示出的正在进行的模式(在其中可以一致地发现高相关性)来延迟治疗。
在另一示例中,还可以通过确定针对聚集的高得分的标准偏差的大小来进一步分析如图8A中示出的模式。如果聚集的高得分基于静态模板并且表现出低标准偏差,则这可以指示单形态状况。在一些实施例中,特别地如果ATP不可用,则可以禁止治疗直到单形态状况分成多更为多形态的状况为止。
在一个示例中,系统使用分层相关性分析来识别可治疗的心律不齐。在该示例中,执行使用静态模板的简单的单个事件相关性分析直到发生在图8A中示出的模式为止。然后这样的模式触发如在图4-5中示出的多个事件间比较。然后,如果事件间比较示出可能的过检测,则可以校正间隔数据。此外,如果事件间比较示出单形态状况,则可以禁止治疗。
图9说明用于将所捕获的信号与相关性分析模板对准并再次对准的方法。在200处示出相关性分析模板,其中在202处示出信号。相关性分析模板200可以是静态模板,或者它可以表示单个检测的事件或若干最近检测的事件的平均。
如在图16中所指出的那样,相关性分析通常将基准点用作一系列有序的模板值和信号采样的对准引导。在图9的示例中,基本对准点被识别为具有最大幅度的信号202和模板200中的每一个的采样。然后进行一系列比较,如在210处示出的那样从基本对准的比较开始,并且如在212处示出的那样向右的单个采样移位,以及如在214处示出的那样向左的单个采样移位。向右移一位的相关性212比基本比较210的相关性得分更差,并且这样的结果是丢弃向右移一位的相关性212。向左移一位的相关性214产生比对准相关性210更高的相关性得分,这样的结果是丢弃基本相关性210,并且如在216处示出的那样计算另一向左移位相关性,这时使对准点偏移两个采样。在216处的结果示出比在214处的向左移一位的相关性更小的相关性,并且因此该过程停止并且将针对向左移一位相关性214所计算的相关性得分用作针对信号202的相关性得分。
当执行向右和/或向左移位时,也可以修改信号到模板的缩放。例如,如果最初通过比较信号的峰值和模板的峰值并且然后在移位时均衡这两个来执行缩放,则在移位发生之后,作为代替,信号的峰值可以被缩放到在模板中它所对准的点。
在图9中示范的方法可以基于采样伪影、转换速率等等帮助校正噪声或未对准,其可能致使采样202的峰值对准点小于最优。该方法包括在基准点被对准时并且还在基准点在两个方向中的每一个方向上以一个或多个采样未对准时计算相关性得分直到发现最大相关性得分时。根据需要,可以对向左或向右移位的采样数目施加限制。在另一实施例中,自动计算若干(例如,一个基本,向左一个、两个和三个,向右一个、两个和三个)得分,并且选择最佳的。
在图9中突出的另一实施例中,可以对模板200定义复数个对准点。一些示例包括QRS发作(onset),最大幅度,最大幅度的相对极性中的最大幅度(注意最大幅度由每一个均为其中dV/dt=0的转折点来指示),两个主要峰值之间的最大斜率点(被示出为dV/dt=MAX等等)。通过识别信号中的类似点,该方法可以确定不同可能的对准点的使用是否将提供不同相关性分析结果。例如,默认的可以是使用整个信号的最大幅度点,但是可能的情况是一些心脏事件能够被对准,而不是使用最大幅度点之后的单调段中的最大斜率点。
图10示出存储并应用用于相关性分析的模板的另一方法。在该示例中,在230处示出形成模板的基础的信号。对于所说明的示例,当形成模板时,在信号230的正峰值和负峰值之间定义内插区域。结果,所存储的模板采用在240处示出的形式:模板240匹配在正峰值之前和负峰值之后的区域的模板信号230,但是它在两个峰值之间是灵活的,如由242处的虚线指示的那样。在所示出的示例中,正峰值是模板中的最大幅度峰值,并且所以它被用来缩放模板至所捕获的信号。
然后如在244处示出的那样执行到采样232的对准。调整该模板以使得正和负峰值与所捕获的信号对准,其之间是线性内插。在正和负峰值之外,模板继续匹配信号,如在230处示出的那样,然而,调整正和负峰值之间的持续时间和斜率以匹配所捕获的事件。在图10中示出的调整可以避免对于其QRS宽度受到速率影响的病人而言在持续时间中固定的静态模板的难题。可以限制所进行的调整以便避免过度加宽模板。
在另一示例中,多于两个模板点被识别并且可以在它们之间使用线性内插。例如,模板可以由五个值组成,每个值具有相对幅度和相对位置。当所检测的事件要与模板比较时,所检测的事件的宽度和峰值幅度被用来缩放模板的每一个值,以及模板点之间的线性内插。
图11-12说明禁止可能的过检测的识别之后的数据校正的方法。
如在图11中示出的那样,在260处发生QRS复合,之后是在262处示出的心室性早期收缩(premature ventricular contraction),之后是在264处示出的另一QRS复合。在该示例中,PVC由与模板的低相关性表征。因此,类似于在上面图3A中示出的那些,出现高-低-高相关性模式。因此一些示例将丢弃PVC 262。然而,分析上来看,丢弃PVC 262可能没必要,因为它实际上不是过检测事件。此外,PVC 262周围的间隔都比500毫秒大。甚至在没有数据校正的情况下,两个间隔的平均将产生大约每分钟103跳的事件速率,这是不会产生威胁以致治疗没有必要的速率。因此,数据校正将不会改进设备中的心律特异性(rhythm specificity),同时减小心跳敏感性。
图12说明一种将避免丢弃如在图11中示出的PVC 262的方法。基于所检测的事件270,如在272处示出的那样该方法确定是否出现将支持双检测(DD)或过检测的发现的相关性得分序列。如果没有,则该方法结束,因为接下来不会发生数据校正。如果来自272的结果是“是”,则该方法接着包括确定由数据校正产生的新间隔是否将大于预定阈值,如在274处示出的那样。在所说明的示例中,该阈值是1000ms(每分钟60跳),不过该数字仅仅是说明性的。一些可能的阈值在750-1200毫秒的范围中。
在另一示例中,颠倒分析的次序,并且不进行过检测分析除非所计算的速率为高(通常150bpm或更多),或者除非所影响的间隔短到足以通过所应用的测试。在另一实施例中,将单独间隔与阈值(例如在400-600ms的范围中)相比,并且如果单独间隔二者都超过阈值,则不会发生间隔组合。在又一示例中,阈值可以是可植入式系统的可编程参数。在另一示例中,可以基于被用来设置将被可植入式系统当作室速速率的心跳速率的可编程VT参数来缩放该阈值。
如果所校正的间隔不比阈值长,则该方法继续组合间隔的步骤(如在276处示出的那样)以校正(一个或多个)过检测事件。如果在步骤274处所校正的间隔比阈值长,则该方法简单地结束,而不组合间隔。可以以这种方式避免所存储的数据的不必要校正。
图13说明用于在过检测的识别之后禁止相关性分析的更多方法。在图13中的方法利用生理心动周期的RR间隔和QT间隔之间的已知关系。所说明的方法同样开始于识别表明过检测的模式,如在300处指示的那样。如在302处示出的那样,可能的过检测的事件于是被当作T波(在这里假设三事件模式被识别,其中三个中的中间事件是可能的过检测;可以使用其他变形),并且如在304处示出的那样,可能的过检测的任一侧的事件被当作R波。
来自步骤302和304的这些“假设的”R和T波然后被用来应用公式来在步骤306中根据RR间隔计算QT长度。特别地,在308处示出了若干可能的公式。示例包括Bazett公式:
Friderica公式:
以及Sagie等人的回归公式:
Sagie等人发现A=0.154。
在每个公式中,预期的QT被示出为QT(exp),以秒给出值RR,并且在植入者和编程者之间的编程会话期间捕获值QT。或者以每分钟60跳的心动速率捕获QT或者将QT调整为每分钟60跳的心动速率。在步骤304中发现RR间隔,并且可以通过将假设的T波的测量宽度加到第一R波和所假设的T波之间的间隔来捕获所测量的QT间隔。
预期如果可能的过检测事件是过检测的T波,则使用无论哪个所应用的公式,所测量的QT时段将匹配给定RR的预期QT值,其中一些带允许误差。
如果在306处应用的公式不产生匹配,则不会发生丢弃,如在310处示出的那样。可替换地,如果在306处应用的公式产生匹配,则如在312处示出的那样丢弃可能的过检测。当在312处丢弃可能的过检测时,组合过检测周围的间隔,如在上面的3B中示出的那样。在其他示例中,再一次颠倒分析的次序。
图14A-14B示出在图13中说明的方法的应用。在图14A和图14B的说明性示例中,应用Friderica立方根公式。在每个示例中,先前测量的QT等于400毫秒。该值表示针对以60bpm的心跳速率发生的假定病人而估计的QT间隔。
参考图14A,给出具有指示过检测的相关性模式的三个事件X、Y和Z,通过假设Y是T波来应用该方法。测量针对X和Y的QT间隔,并且如所指示的那样,测量从X到Z的RR间隔。还参考所测量的QT,并且这些值被插入到所选的公式中。在该示例中,示出使用RR=0.8秒,针对QT的预期值是371毫秒。应用针对计算的+/-10%误差带,对于QT来说所接受的范围是大约334-408毫秒。然而,如所示出的那样,所测量的间隔是大约500毫秒,对于给定参数,它太长以至于无法成为QT间隔。结果,该计算表明Y检测不是过检测的T波,并且因此不发生数据校正。可以应用更小或更大的误差带大小;例如在另一说明性实施例中使用+/-5%。
作为代替,参考图14B,这次,针对X和Y而测量的QT间隔是大约370毫秒。该值落入预期范围内,并且该因此计算表明Y检测是过检测的T波。因此,Y检测被丢弃并且X和Z之间的间隔数据被校正。
在图11-13和14A-B的示例中,如果可能的过检测不被丢弃,导致在数据校正中,作为代替可能的过检测可以被标记为可疑检测。在一个示例中,可疑检测被当作是不可靠的,作为心搏的指示器以及作为可以在速率分析中使用的间隔的端点这二者都是如此。如果可能的过检测被标记为可疑检测,则从分析中整体移除可疑检测以及可疑检测周围的在前和在后间隔中的每一个。
图15示出用于识别可电击所检测事件和可治疗心律的分析方法。图15示出分析方法的总体结构,该分析方法包括步骤:事件检测402,之后是波形评价404和心跳限制(qualification)406。特别地,事件检测402通常将包括监控所捕获的信号以检测指示心脏事件的信号幅度变化。一旦在块402处捕获心脏事件,波形评价404就可以发生。在波形评价404期间,与所检测事件相关联的信号的特性被分析以识别并消除有可能因噪声或伪影引起的所检测事件。
接下来,通过波形评价404的所检测事件经历心跳限制406,其间分析所检测事件以确定它们是否显示指示准确检测的形态或间隔特性。这可以包括上文示出的相关性分析,和/或间隔的分析或两个的组合,例如消除宽复合双检测的分析可以使用所检测事件接近性,并且为特性定形以识别可能的过检测。在名称为METHODS AND DEVICES FOR ACCURATELY CLASSIFYING CARDIAC ACTIVITY序列号为12/399,914的美国专利申请中给出一些其他讨论。
然后该架构转向心律分类,其可以通过在块408处考虑速率来开始。如果速率为低,则单独检测被标记为“不可电击”,如在410处指示的那样。可替换地,如果速率非常高,则认为其指示室颤(VF)并且因此被标记为“可电击的”,在412处示出的那样。在速率的这些低和VF带之间的是室速(VT)区,并且使用将被称为检测增强的那些手段来分析VT区中的速率,如在414处所示出的那样。
检测增强的示例如下:
1.与静态模板相比:如果匹配,则是不可电击的;否则
2.与动态模板相比:如果不匹配,则是可电击事件;否则
3.与QRS宽度阈值相比:如果宽,则是可电击的,否则是不可电击的
其中动态模板可以是下述任一个:
a)彼此相关的若干先前检测的平均;
b)单独事件的集合,例如{N-1…N-i},其中当匹配动态模板时匹配单独事件计数中的一些或所有;
c)连续更新的模板。
可以以各种方式来应用上面提到的QRS宽度阈值,所述各种方式适合于在给定系统中使用的QRS宽度测量方法和/或所述各种方式可以适合于单独病人。在一个示例中,将下面的规则应用于QRS宽度:
x)在分析期间,计算作为从基准点之前的不反应期间所捕获的最长单调段的开始到在基准点之后的不反应期间所捕获的最长单调段的结束的持续时间的QRS宽度;
y)利用所允许的最大值113ms来在编程会话期间为病人测量QRS宽度阈值;并且
z)如果QRS宽度比QRS宽度阈值长至少20ms,则在分析期间认为该QRS宽度宽
这些规则x)、y)、z)适合于一个特定实施例并且可能根据所使用的系统而改变。
在将事件标记为不可电击410或可电击412之后,如在416处指示的那样应用X/Y计数器条件。X/Y计数器条件分析在通过波形评价404和心跳限制406的所检测事件Y的先前集合期间被标记的可电击事件X的数目。所应用的比率和所使用的集合大小可以改变。在416处,一个实施例应用18/24 X/Y计数器条件。其他实施例使用12中的8或9,16中的12或13,24/32等比率。
如果不满足X/Y条件,则将不递送电击,如在418处示出的那样。如果满足X/Y条件,则该方法可以继续进行到充电确认块420。例如,一些实施例需要针对所选数目的连续事件满足X/Y比率/集合大小,并且在充电确认420中可以测试该条件。另一示例条件是确定N个紧接在前的检测事件的集合是否都是可电击的,或者所有都具有足够短以支持所检测的心律不齐正在进行的结论的间隔。在充电确认中还可以应用其他因素,例如通过观察最近是否已经记录过检测(这可以表明治疗应该被延迟以确保“心律不齐”不是过计数的表现),或者观察是否已经检测到一致的长间隔(潜在地表明病人自发转换到正常心律)。例如,充电确认420还可以包括诸如共同转让共同待决的名称为METHOD FOR ADAPTING CHARGE INITIATION FOR AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR编号为11/042,911的美国专利中示出的那些方法之类的方法,通过参考将其结合于此。
如果通过充电确认420,则到达充电和电击块422。典型地,充电的过程花费一定时间段,并且因此方法400可以在充电完成之前迭代若干次。可以在该过程期间重复用于达到应该开始充电的初始确定的一些或所有分析。最后,如果在充电期间可治疗的状况持续,或者在充电之后识别可治疗的状况,则可以递送刺激。
关于可植入式系统,可以结合各种硬件特征。例如,可以使用任何适当的化学电池,例如锂离子电池。可以使用电容系统来存储能量直到使用一个或若干电容器达到刺激电平,从而创建治疗输出。可以使用诸如回扫(flyback)变压器电路之类的充电电路来生成治疗电压。可以使用例如H桥电路或其修改来递送该治疗。可以使用专用或通用电路来执行分析功能。例如,根据需要,可以使用专用心脏信号模拟到数字电路,以及专用相关性分析块,同时可以利用微控制器来执行其他功能。可以提供静态和动态存储器,并且可以针对任何适合的功能来使用所述静态和动态存储器。所有这些元件可以都是可植入式心脏刺激系统的操作电路的部件。
本领域技术人员将会认识到可以以不同于本文所预期和描述的特定实施例的各种形式来表明本发明。因此,可以进行形式和细节上的偏离,而不偏离本发明的范围和精神。
Claims (8)
1.一种可植入式心脏刺激(ICS)系统,其包括:容纳用于ICS系统的操作电路的罐,所述罐具有布置在其上的罐电极;以及引线,具有布置在其上的至少第一引线电极,所述罐电极和所述第一引线电极电耦合到操作电路;其中所述操作电路被配置成执行包括下述步骤的方法:
检测在病人内发生的电事件;
构造所检测电事件的事件表示,所述事件表示每个都包括一系列采样;
通过识别第一事件表示中的事件基准点以及将模板基准点与所述事件基准点彼此对准以及当这样被对准时计算第一事件表示和模板之间的第一相关性,来将第一事件表示和具有模板基准点的模板相比较;
再次将第一事件表示和模板相比较,这次是通过选择模板和事件基准点的不同对准;
至少从第一相关性或第二相关性选择指示比针对第一事件表示的相关性结果更大的相关性的无论哪个相关性;
使用一系列相关性结果来确定是否发生准确事件检测,并且如果没有则响应于不准确的事件检测而校正数据;
确定是否发生可能的心律不齐,并且如果发生,则确定是否需要刺激;以及
如果需要刺激,则将电刺激从ICS系统递送到病人。
2.根据权利要求1所述的ICS系统,其中所述操作电路还被配置成使得该方法还包括另一步骤:通过使事件基准点与模板基准点不对准并且计算第一事件表示和模板之间的第三相关性来将第一事件表示和模板相比较;其中
利用模板基准点之前一个或多个采样处对准的事件基准点来计算第二相关性,以及利用模板基准点之后一个或多个采样处对准的事件基准点来计算第三相关性。
3.根据权利要求1所述的ICS系统,其中所述操作电路还被配置成使得:
利用在第一方向上远离模板基准点一个采样处对准的事件基准点计算第二相关性;
如果第二相关性大于第一相关性,则该方法还包括另一步骤:通过在第一方向上远离模板基准点两个采样处对准事件基准点以及计算第一事件表示和模板之间的第三相关性来将第一事件表示和模板相比较;或者
如果第二相关性小于第一相关性,则该方法还包括操作电路执行另一步骤:通过在与第一方向相反的方向上远离模板基准点一个采样处对准事件基准点以及计算第一事件表示和模板之间的第三相关性来将第一事件表示和模板相比较。
4.根据权利要求1所述的ICS系统,其中所述操作电路还被配置成使得使用一系列相关性结果来确定是否发生准确事件检测的步骤包括:确定是否发生相关性结果的交替的高-低-高模式,并且如果发生,则确定具有低相关性结果的事件表示由过检测信号产生。
5.根据权利要求1所述的ICS系统,其中所述操作电路还被配置成使得该方法还包括通过将第一事件表示的相关性结果和阈值相比较来确定一系列所检测事件是可电击的还是不可电击的,并且如果相关性结果超过阈值,则确定对应于第一事件表示的所检测事件是不可电击的。
6.一种可植入式心脏刺激(ICS)系统,其包括:容纳用于ICS系统的操作电路的罐,所述罐具有布置在其上的罐电极;以及引线,具有布置在其上的至少第一引线电极,所述罐电极和所述第一引线电极电耦合到操作电路;其中所述操作电路被配置成执行包括下述步骤的方法:
检测在病人内发生的心脏电事件;
构造所检测电事件的事件表示;
使用所检测电事件的集合来计算心率;
将事件表示和表示已知心脏状态的模板相比较以建立相关性集合;
针对下述各项之一来分析相关性集合:
a)要求3个或更多连续相关性的集合以在第一边界周围包括高-低-高模式的短模式,或者
b)要求5个或更多连续相关性的集合以在第二边界周围包括高-低-高-低-高相关性的长模式,
其中与第二边界相比,第一边界对于“高”需要更强的相关性;
如果识别出短模式或长模式,则将一个或多个所检测事件表征为过检测并且修改所计算的心率;
确定是否发生可能的心律不齐,并且如果发生,则确定是否需要刺激;并且
如果需要刺激,则将电刺激从ICS系统递送到病人。
7.根据权利要求6所述的ICS系统,其中所述第二边界通过下述方式定义:
识别相关性集合中的平均相关性;以及
将上限建立为平均相关性之上的设定距离。
8.根据权利要求6所述的ICS系统,还包括针对下述内容来分析检测的集合:
c)包括高-低-低相关性的至少两个序列的三模式,
其中如果识别出三模式,则该方法包括将每个“低”事件表征为过检测,并且计算在重新计算速率中使用的高事件之间的间隔。
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US8880161B2 (en) | 2008-05-07 | 2014-11-04 | Cameron Health, Inc. | Methods and devices for accurately classifying cardiac activity |
US9265432B2 (en) | 2008-05-07 | 2016-02-23 | Cameron Health, Inc. | Methods and devices for accurately classifying cardiac activity |
US9763619B2 (en) | 2008-05-07 | 2017-09-19 | Cameron Health, Inc. | Methods and devices for accurately classifying cardiac activity |
US10709379B2 (en) | 2008-05-07 | 2020-07-14 | Cameron Health, Inc. | Methods and devices for accurately classifying cardiac activity |
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